There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

This paper explores the characteristics of health technology assessment (HTA) systems and practices in Asia. Representatives from nine countries were surveyed to understand each step of the HTA pathway. The analysis finds that although there are similarities in the processes of HTA and its application to inform decision making, there is variation in the number of topics assessed and the stakeholders involved in each step of the process. There is limited availability of resources and technical capacity and countries adopt different means to overcome these challenges by accepting industry submissions or adapting findings from other regions. Inclusion of stakeholders in the process of selecting topics, generating evidence, and making funding recommendations is critical to ensure relevance of HTA to country priorities. Lessons from this analysis may be instructive to other countries implementing HTA processes and inform future research on the feasibility of implementing a harmonized HTA system in the region.

Objectives Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. Methods The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. Results A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. Conclusions The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

Abstract-Achievement of universal health coverage requires better allocative efficiency in health systems. Countries like the Philippines, however, do not have quality local data for these decisions. We present a method that applies existing global data, e.g., Global Burden of Disease and Disease Control Priorities project, into creating a local priority list of diseases and interventions that may be useful in providing a rational plan for expanding coverage of health services paid by public financing. In the context of the Philippines, this refers to the Department of Health for vertical programs like immunization and disease control, and the Philippine Health Insurance Corporation for inpatient and outpatient health services. We found that the top 48 (or 22%) of diseases account for 80% of total disability-adjusted life years (DALYs), reflecting a well-known concept in management, the Pareto principle. Due to its simplicity and widespread applicability, the Pareto principle facilitated interest in rational priority setting among high-level officials in the Philippine health sector. Priority setting must not be limited to disease burden and cost-effectiveness criteria. Our lists can be used after further deliberation and stakeholder consultation. Priority setting is a complex, value-laden process, and a purely utilitarian approach to prioritization may lead to further deterioration in the health status of vulnerable populations. We recommend that DOH and PHIC set up a joint, independent agency primarily responsible for implementing a sustainable, transparent, and participatory priority-setting process that will advise them on future service coverage expansions.

Aim Kidney failure patients in the Philippines have free choice on their kidney replacement therapy (KRT), with a majority choosing haemodialysis (HD) over peritoneal dialysis (PD) and transplantation despite the inadequate coverage of HD. Although national health insurance coverage is limited, KRT remains to be one of the top benefits pay‐outs in the country. The study aims to identify the most cost‐effective policy strategy for financing KRT in the Philippines, in the context of a universal healthcare policy. Methods A Markov model was developed to estimate and compare the costs and benefits of different policy options with the comparator being partial HD coverage. Direct medical, non‐medical and indirect costs were measured, while outcomes were reported through quality‐adjusted life years (QALYs). Parameters were derived from the kidney disease registry, hospital statistics from a tertiary hospital and a patient survey. Results The results of the cost‐effectiveness analysis showed that shifting to a PD‐First policy provides better value‐for‐money with an incremental cost‐effectiveness ratio (ICER) of 570 029 Philippine Pesos (PHP) per QALY gained, compared with the ICER of the PD‐First combined with pre‐emptive transplant option of 577 989 PHP per QALY gained. Expanding existing HD coverage to 156 sessions was the least cost‐effective policy (1 522 437 PHP per QALY gained). Conclusion Government should consider shifting to a PD‐First strategy and support policies that promote kidney transplants among existing PD and HD patients. This study also highlights the need for proper evaluation of partial coverage policies to ensure that government investments represent good value‐for‐money and patients receive optimal care.

This article is part of a series commissioned by The BMJ. Open access fees are paid for by the Bill and Melinda Gates Foundation, which had no role in the decision to publish.

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